Medical devices are instrumental in saving or prolonging countless lives. Examples of medical devices include dialysis machines, heart lung machines, respirators, electrocardiogram machines, defibrillators, and pacemakers. Because human lives are at stake, it is of critical importance to avoid malfunctions in such medical devices. Many medical treatment systems may benefit from frequent upgrades of their capabilities, but such upgrades can run the risk of modifying the behavior of treatment systems in unexpected ways, creating risk. For example, many sophisticated treatment devices such renal replacement therapy machines employ software in their control and performance monitoring mechanisms. Software is easily modified, but can profoundly impact safety. In its General Principles of Software Validation; Final Guidance for Industry and FDA Staff Document issued on: Jan. 11, 2002, the Food and Drug Administration (FDA) reported its analysis of 3140 medical device recalls conducted between 1992 and 1998, which revealed 7.7% were attributable to software failures. Of those software related recalls, 79% were caused by software defects that were introduced when changes were made to the software after its initial production and distribution.
In addition to the risk, government regulation of medical devices make upgrades expensive for manufacturers and vendors and impose delays in the introduction of improved systems. To protect the public from failures caused by system upgrades, governments often regulate the sale and use of medical devices and require additional testing and proof of safety every time a treatment device is modified. When a manufacturer wishes to release an improved version of a device, the manufacturer must go through expensive, and time-consuming regulatory approval process to establish the efficacy and safety of the improvements. Because of this, many patients are deprived from the benefits that recent advances in medical technology might otherwise provide. In regimes where such testing is not onerous, the risk is still present.